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Title: A New Rotational Thrombectomy Catheter: System Design and First Clinical Experiences

Journal Article · · Cardiovascular and Interventional Radiology
DOI:https://doi.org/10.1007/S002709900440· OSTI ID:21080256
 [1];  [2];  [1];  [3];  [2];  [1]
  1. Department of Diagnostic Radiology, University Hospital Basel, Kantonsspital, CH-4031 Basel (Switzerland)
  2. Department of Medicine, Division of Angiology, University Hospital Basel, Kantonsspital, CH-4031 Basel (Switzerland)
  3. Straub Medical, Straubstrasse, CH-7323 Wangs (Switzerland)

Purpose: To describe a new catheter for the percutaneous mechanical removal of fresh and organized thrombi, and to assess its efficacy and safety in vitro and in vivo. Methods: The catheter consists of a coated stainless steel spiral that rotates at 40,000 rpm over a guidewire inside the whole length of an 8 Fr, single-lumen, polyurethane catheter, driving a dual-blade cutting crown. Abraded occlusion material is sucked into the catheter head through distal side holes and transported by the spiral into a reservoir at the proximal end. The efficacy of the device was tested in arterial models and fresh bovine carotid arteries (n = 72). In a clinical pilot study 10 patients (8 women, 2 men; mean age 70.6 {+-} 10.1 years) with occlusions of the superficial femoral artery (2-12 cm, mean 5.8 cm), not older than 4 weeks, underwent thrombectomy with the new catheter. Results: In arterial models and bovine cadaver arteries the catheter completely removed fresh thrombi. Occlusion material of higher consistency was cut into particles of 100-500 {mu}m and transported outside. Thrombectomy was successful and vessel patency restored in all 10 patients. The ankle/brachial pressure index significantly (p < 0.0005) increased from 0.41 {+-} 0.18 before intervention to 0.88 {+-} 0.15 after 48 hr and to 0.84 {+-} 0.20 after 3 months. Two reocclusions occurred within 14 days after the intervention. Conclusion: Thrombectomy with the new device appears to be feasible and safe in patients with acute and subacute occlusions of the femoropopliteal artery.

OSTI ID:
21080256
Journal Information:
Cardiovascular and Interventional Radiology, Vol. 22, Issue 6; Other Information: DOI: 10.1007/s002709900440; Copyright (c) 1999 Springer-Verlag New York Inc; Country of input: International Atomic Energy Agency (IAEA); ISSN 0174-1551
Country of Publication:
United States
Language:
English